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Buffer Management Solutions For Large-Scale Bioprocessing Buffer Management Solutions For Large-Scale Bioprocessing

How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

Scalable Strategies For Parenteral Dosage Form Selection Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.


On Target With Antibody Drug Conjugates

Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

Accelerating Lipid-Based Drug Formulation

Formulation scientistsmust develop and validat robust systems that address the challenges posed by increasingly complex drug candidates, in ever shortening time frames.

Liquid Filled And Sealed Hard Gelatin Capsules
This article will review the categories of drugs for which the liquid and semi-solid filled capsule is particularly relevant, examine the compatibility issues associated with excipients, compare the liquid filled and sealed hard gelatin capsule with soft gelatin capsules, and also describe a new process for sealing hard gelatin capsules. Submitted by Capsugel
In Vivo Study And The Impact Of The Dissolution Rate On Bioequivalence

Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.

More From OP White Papers - random


Optimization For Scale Up Of Low- Dose API Roller Compaction

Because of the numerous challenges involved in the roller compaction of low dose active pharmaceutical ingredients, Patheon, Inc. recently conducted a study to determine the optimal design space and scale up conditions for such an application. They also set out to minimize the amount of active pharmaceutical ingredients needed in the early stages of drug development in order to save on costs and overcome short supply issues that are typical during the earlier stages of drug development. Read on to learn what they found out.

Automated Cross Flow Filtration For Process Development, Filter Screening, And Process Optimization At Small Scales

This application note focuses on microfiltration (pore sizes between 0.1 µm and 1 µm). Microfiltration is ideally suited for separation of cultured cells from the growth medium (broth), as well as for sterilization, and contaminant and particle removal in numerous biopharmaceutical processes

GE Works On Single-Use Film To Achieve Optimal Performance In Biomanufacturing

The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.

Single-Use vs Stainless: An Economic Microbial Fermentation Comparison

In this case study, we compare production capacity and process economy between stainless steel and single-use equipment in microbial processes. Economy simulations were based on an E. coli Dab process. Production scenarios in both single- and multi-product facilities were considered.

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles




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